BABY INFANT EARACHE DROPS- belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid

BABY INFANT EARACHE DROPS by

Drug Labeling and Warnings

BABY INFANT EARACHE DROPS by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., Lifetech Resources. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Belladonna 30C HPUS (less than 0.0000000000001 % Alkaloids, calculated): fever
• Calcarea Carbonica 30C HPUS: throbbing ear pain
• Chamomilla 30C HPUS: occasional sleeplessness and irritability
• Lycopodium 30C HPUS: ear pain
• Pulsatilla 30C HPUS: ear itching, pain worse at night
• Sulphur 30C HPUS: ear pain with burning

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States

PURPOSE

Temporarily relieves the symptoms of fever, pain, throbbing, irritability, and occasional sleeplessness associated with earaches in children after diagnosis by a physician. Relieves common pain and itching of swimmer's ear.

Uses

Temporarily relieves the symptoms of fever, pain, throbbing, irritability, and occasional sleeplessness associated with earaches in children after diagnosis by a physician. Relieves common pain and itching of swimmer's ear.

Warnings

Keep away from eyes. Do not take by mouth.

Earache drops are only to be used in the ears. Tip of applicator should not enter ear canal. Consult a physician if:

• Symptoms persist for more than 48 hours
• Discharge from ear is present

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if tamper band is broken or missing.

In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

Children under 3 years of age: Tilt head sideways and apply 3-4 drops into involved ear 4 times daily or as needed. Tilt ear upward for at least 2 minutes after application, or gently place cotton in ear to keep drops in.

Inactive ingredients

Citric Acid,Glycerine, Purified Water, Sodium Benzoate.

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

NDC: 54973-7516-3
HOMEOPATHIC

Ages

6 months+

SINCE 1903
Hyland's ®
Baby

Natural
Relief

Infant
Earache Drops

FAST, SOOTHING

RELIEF OF EAR PAIN
AND IRRITABILITY*

‣ No Antibiotics, Artificial Flavors, Dyes or Parabens

0.33 FL.OZ. (10mL)

INGREDIENTS AND APPEARANCE

BABY INFANT EARACHE DROPS 
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-7516
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	30 [hp_C]  in 1 mL
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	30 [hp_C]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]  in 1 mL
ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD)	ANEMONE PATENS	30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-7516-3	1 in 1 CARTON	03/16/2004
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/16/2004

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-7516) , pack(54973-7516)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-7516) , pack(54973-7516)